Topical testosterone (T) for promoting hair growth—containing formulations

Abstract

The present invention relates to the composition and method of use for the topical application of the potent androgen hormone dihydrotestosterone (DHT), used alone or in fixed combination with other hair growth medications; including other androgens, bimatoprost, other prostamides, prostaglandins, minoxidil or apocrine hair growth factors to promote and enhance hair growth of terminal mustache hair, beard hair, also chest hair, and other male androgen sensitive or dependent hair growth in humans or animals.

What is claimed is: 
     
       1. A method for promoting and enhancing facial hair growth in an adult human male who has completed puberty and has a level of circulating androgen hormones that are within a normal physiologic reference range, wherein said adult human male is unable to grow a full beard and/or mustache but otherwise has classic male secondary sex characteristics, comprising topically administering an effective amount of a pharmaceutically acceptable formulation of testosterone (T) to a target skin area, which is the mustache region, beard region, or both of said adult human male, and wherein the target skin area has sparse mature terminal hair, thereby promoting or enhancing growth of mature terminal hair at the target skin area; wherein said adult human male does not have a genetically determined lower level of intracellular 5 alpha reductase and does not have a genetically determined lower number of androgen receptors. 
     
     
       2. The method as claimed in  claim 1 , in which said administration is repeated daily until desired hair growth results. 
     
     
       3. The method as claimed in  claim 1 , wherein said formulation is selected from the group comprising topical liquids, lotions, creams, ointments, solutions, gels, foams, aerosols, or sprays. 
     
     
       4. The method as claimed in  claim 1 , in which said formulation is formulated to deliver said testosterone (T) to the hair follicles and hair follicle bulb matrices of hair in said target skin area. 
     
     
       5. The method as claimed in  claim 1 , in which said formulation is formulated to deliver said testosterone (T) to the hair follicle and the mesenchymal dermal papilla cells of said hair follicle in said target skin area. 
     
     
       6. The method as claimed in  claim 4 , in which said formulation is adsorbed onto or into a hair shaft and drawn by capillary action to said hair follicle bulb and other parts of the hair follicle. 
     
     
       7. The method as claimed in  claim 4 , in which said formulation crosses the surface of the skin and is transported to said hair follicle bulb matrix by trans-epidermal diffusion or by transdermal diffusion. 
     
     
       8. The method as claimed in  claim 7 , in which said formulation additionally comprises one or more dermal penetration enhancement agents. 
     
     
       9. The method as claimed in  claim 8 , in which said dermal penetration enhancement agent comprises one or more alcohols selected from the group consisting of methanol, ethanol, propanol, and isopropanol. 
     
     
       10. The method as claimed in  claim 8 , in which the concentration of said dermal penetration enhancement agent is no greater than a concentration sufficient to enhance testosterone (T) penetration to layers of dermis containing hair follicle bulb matrices. 
     
     
       11. The method as claimed in  claim 10 , in which said dermal penetration enhancement agent concentration is formulated so as to deliver said testosterone (T) to said hair follicle bulb matrices, but that said testosterone (T) is not significantly absorbed into the systemic circulation. 
     
     
       12. The method as claimed in  claim 11 , wherein said testosterone (T) concentration is in a range of from about 0.5% to about 25%, weight to weight. 
     
     
       13. The method as claimed in  claim 11 , wherein said testosterone (T) concentration is in a range of from about 0.5% to about 25%, weight to volume. 
     
     
       14. The method as claimed in  claim 11 , wherein said testosterone (T) concentration is in a range of from about 0.5% to about 25%, volume to volume. 
     
     
       15. The method as claimed in  claim 11 , in which said testosterone (T) formulation additionally comprises benzalkonium chloride in a range of about 0.2 mg/mL to 0.5 mg/m L. 
     
     
       16. The method as claimed in  claim 11 , in which said testosterone (T) formulation additionally comprises sodium chloride, dibasic sodium phosphate, citric acid or pharmaceutically acceptable purified water.